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A Multicentre Randomised Controlled Trial and Mechanistic Exploration of Dual-Target Magnetic Stimulation Modulating the Brain-Gut Axis for the Treatment of Slow-Transit Constipation Comorbid with Anxiety and Depression Disorders

A Multicentre Randomised Controlled Trial and Mechanistic Exploration of Dual-Target Magnetic Stimulation Modulating the Brain-Gut Axis for the Treatment of Slow-Transit Constipation Comorbid with Anxiety and Depression Disorders

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106635
Enrollment
Unknown
Registered
2025-07-28
Start date
2025-08-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Slow transit constipation

Interventions

Dual-target magnetic stimulation group:Repetitive transcranial magnetic stimulation and sacral nerve magnetic stimulation
single stimulus group:Pseudo-repetitive transcranial magnetic stimulation and sacral nerve magnetic stimulation

Sponsors

Chengdu Anorectal Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Meets the Rome IV diagnostic criteria for chronic functional constipation, with a disease duration of at least 6 months; (2) Age: over 18 years old; (3) Can be clearly diagnosed with generalised anxiety disorder or major depressive disorder according to DSM-5 criteria; (4) Positive colon transit test; (5) Patient informed consent and voluntary participation in the study.

Exclusion criteria

Exclusion criteria: (1) Exclude central nervous system disorders such as Parkinson's disease, stroke, traumatic brain injury, cerebral palsy, multiple sclerosis, and peripheral nerve disorders such as diabetic peripheral neuropathy and metabolic peripheral neuropathy; (2) Exclude constipation caused by organic colonic lesions, such as colonic tumours, megacolon, and colonic diverticula; (3) History of major abdominal or perineal surgery, such as colostomy (excluding minor surgeries like appendectomy or haemorrhoidectomy), and coexisting other types of intestinal diseases like intestinal obstruction or inflammatory bowel disease; (4) Uncontrolled hypertension; (5) Pregnancy or lactation period; (6) Individuals with infections in the sacral 2-4 region and the corresponding DLPFC region of the head; (7) Individuals with a pacemaker or other metallic devices; (8) Patients with cognitive impairments who cannot cooperate; (9) Alcohol abuse; (10) Individuals unable to undergo electrode placement due to anatomical limitations; (11) Individuals currently participating in other clinical trials.

Design outcomes

Primary

MeasureTime frame
Colon transit test;High-resolution anorectal manometry;

Secondary

MeasureTime frame
Constipation Severity Instrument;DASS-21;Genital nerve motor evoked potential;SF-36 QoL;

Countries

China

Contacts

Public ContactChunmei Luo

Chengdu Anorectal Hospital

1179545565@qq.com+86 187 0810 2327

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026